Fact Sheet

Intego - Mycoplasma Testing

Interest Group

ATMP manufacturer, pharmaceutical industry, media manufacturer.

Description

Direct mycoplasma testing method especially designed for cell culture materials and ATMPs according to EP 2.6.7.

Recommended Sample Material

Cell cultures, cryo-stocks, sera, antibody formulations, autologous material and many more.

Method

Qualitative Real-Time PCR.

Applied PCR System

Microsart® ATMP Mycoplasma (Sartorius Biotech GmbH), Venor GeM qEP (Minerva Biolabs GmbH).

Applied Extraction

InviMag I/G Universal (Stratec Molecular GmbH), QiaAMP DSP Virus Spin Kit (Qiagen AG) and Venor GeM Sample Preparation Kit (Minerva Biolabs GmbH).

Process Control

Extraction and Amplification.

Sample Volume / PCR

10 µl.

Average Turnaround Time

24 to 48 hours after sample receipt, express testing scheme* possible.

Sensitivity of Method

10 CFU / ml.

Regulatory Compliance

EP 2.6.7 compliant for ATMPs. Please note, a validated procedure is available for standard sample materials only. For any other materials an individual validation may be required to demonstrate the efficiency of the pre-analytical procedure in means of sensitivity. Please contact us for further information.

Sample Requirements

Minimum: 600 µl
Optimum: 2 units of 600 µl each, label as sample A and sample B (backup, please mark in accession form).

Order No.

Mycoplasma Testing ‘Intego’      41-1012

Volume Discount Available

Yes, on request.

Additional Information

Please note: repetitions which are not caused by our laboratory and *express testing schemes are subject to additonal charges. Please contact us for further information.